Donor-derived Cell Free DNA as a New Biomarker in Cardiac Acute Rejection
- Conditions
- Heart Transplant Rejection
- Registration Number
- NCT04973943
- Lead Sponsor
- Puerta de Hierro University Hospital
- Brief Summary
FreeDNA-CAR is a prospective, observational multicenter study, that will include a total of 200 adult heart transplant (HT) patients from 14 centers in Spain. Our main objective is to test donor-derived Cell-Free DNA (dd-cfDNA) against endomyocardial biopsy (EMB) for the diagnosis of acute cellular rejection.
- Detailed Description
All patients will be enrolled immediately after HT, and will undergo undergo routine surveillance EMB at 15 days, 1 month, 2, 3, 4, 6 and 12 months after HT. Simultaneously with each EMB, dd-cfDNA will be measured in plasma.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
- Patients > 18 years old who undergo heart transplant during the recruiting period
- Patients with moderate or severe Primary Graft Dysfunction
- Patients on invasive mechanical ventilation 15 days after heart transplant
- Patients on renal replacement therapy, continuous or periodic, 15 days after heart transplant
- Heart Transplant due to a cardiomyopathy that could potentially recur on the graft (cardiac amyloidosis, Chagas disease or sarcoidosis, amongst others)
- Multiorgan transplant
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Association between dd-cfDNA levels and the presence of acute cellular rejection 1 year Association between dd-cfDNA levels above a certain cut-point and the presence of treatable acute cellular rejection as determined by endomyocardial biopsy (graded by International Society of Heart and Lung Transplantation 2010 classification, grade \> 1R).
- Secondary Outcome Measures
Name Time Method Area under curve for dd-cfDNA 1 year To define a cutt-off point of dd-cfDNA level with a high negative predictive value that could obviate the need to perform surveillance endomyocardial biopsies
Correlation between dd-cfDNA and antibody mediated rejection (AMR) 1 year Correlation between dd-cfDNA and antibody mediated rejection (AMR)
Determine a cut-off point of dd-cfDNA that allows to differentiate between acute cellular rejection (ACR) and antibody mediated rejection (AMR) 1 year Determine a cut-off point of dd-cfDNA that allows to differentiate between acute cellular rejection (ACR) and antibody mediated rejection (AMR)
Association between dd-cfDNA and immunosuppressive (IS) treatment 1 year Subanalysis of association between dd-cfDNA and rejection stratified by IS regimen (type and dose of drug).
Association between dd-cfDNA (%) and left ventricular ejection fraction 1 year Association between dd-cfDNA and left ventricular ejection fraction (LVEF). All echocardiograms will be performed on the same day of EMB.
Determine the biomarker's kinetics at 15 days post-transplant 15 days Determine dd-cfDNA levels at 15 days post-transplant in absence of rejection
Association between dd-cfDNA levels and cytomegalovirus (CMV) infection 1 year Association between dd-cfDNA levels and CMV infection as determined by CMV polymerase chain reaction (number of copies per ml)
Trial Locations
- Locations (12)
Clinica Universitaria de Navarra
🇪🇸Pamplona, Navarra, Spain
Hospital Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
University Hospital Puerta de Hierro
🇪🇸Majadahonda, Madrid, Spain
Hospital Universitario A Coruña
🇪🇸A Coruña, Spain
Hospital 12 octubre
🇪🇸Madrid, Spain
Hospital Bellvitge
🇪🇸Barcelona, Spain
Hospital La Fe
🇪🇸Valencia, Spain
Hospital Clinic de Barcelona
🇪🇸Barcelona, Spain
Hospital Virgen de la Arrixaca
🇪🇸Murcia, Spain
Hospital Virgen del Rocio
🇪🇸Sevilla, Spain
Hospital Universitario Gregorio Marañón
🇪🇸Madrid, Spain
Hospital Universitario Central de Asturias
🇪🇸Oviedo, Asturias, Spain